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Trial Summary

This study aims to test the safety and tolerability of ST-617 on patients and their oral cavities while they are being treated with chemoradiation for head and neck cancer. There are two arms to this study, Phase 1b and Phase 2. It is hoped that the Phase 1 arm will help determine the recommended dose of ST-617 that will be used in head and neck cancer patients in the Phase 2 study.

Acronym:

ST 617-101

ACTRN/NCT /ethics:

ACTRN12620000541909

Scientific title:

A Phase 1b, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ST-617 for the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for Head and Neck Cancer

Sponsor / Cooperative group:

Supportive Therapeutics (Pty) Ltd

Trial & Patient Characteristics

Cancer TypeHead and Neck
Trial TypeTreatment
PhasePhase I; Phase II
Age Range18 years and older
SexBoth
Tumour Stream Head and Neck
Cancer StageAll stages
Anticipated Start Date2019-11-12
Anticipated End Daten/a

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorAlex Scott-Hoy
Emailalex.scott-hoy@sa.gov.au
Phone08 8204 4830
Principal InvestigatorDr Shawgi Sukumaran
Recruitment StatusRecruiting
HospitalRoyal Adelaide Hospital
Clinical Trial CoordinatorAnne Milton
Emailanne.milton@sa.gov.au
Phone08 7074 2342
Principal InvestigatorDr Hien Le
Recruitment StatusRecruiting